NICE against new indication for Novartis' Lucentis

Draft guidance says the eye drug should not be used to treat visual impairment caused by macular oedema

NICE has come out against the use of Novartis' eye care drug Lucentis (ranibizumab injection) in new indication in England and Wales.

The cost effectiveness body's draft guidance “gaps and uncertainties” in the evidence of the effectiveness of ranibizumab compared with other treatments currently used in the UK.

The National Institute for Health and Clinical Excellence (NICE) is currently assessing Lucentis as a treatment of visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion (RVO).

NICE's appraisal committee was also critical of Novartis' analysis of the drug and said it “was not a true reflection of clinical practice or the efficacy of ranibizumab”.

The Institute said Novartis underestimated the incremental cost-effectiveness ratio (ICER) for Lucentis compared with standard care, with the company making outlook assumptions that were not plausible.

Its draft guidance concluded the ICER for Lucentis in central RVO versus Allergan's Ozurdex (dexamethasone) intravitreal implant, the currently approved treatment, was likely to be over £37,400 per QALY gained.

Dr Carole Longson, Health Technology Evaluation Centre director at NICE, said: "The independent Appraisal Committee recognises the profound effect that RVO can have on everyday life. However, in order for NICE to recommend any drug or technology, we have to be sure that it is both clinically effective and good value for money.”

Ozurdex was recommended by NICE earlier this year as a cost-effective treatment for the same indication because it “improves vision compared with best supportive care” with benefits outweighing additional costs.

The news comes the same week as Regeneron Pharmaceuticals' Eylea (aflibercept), a rival drug to Lucentis, was approved by the US Food and Drug Administration (FDA) to treat patients with wet (neovascular) age-related macular degeneration (AMD) – a growth of abnormal blood vessels in the eye.

NICE will now consult on its draft guidance for Lucentis, with final guidance likely to be published in March 2012.